FDA.reportPublic FDA data

Nighttime Cold and Flu Relief

Manufacturer
AiPing Pharmaceutical, Inc. | Anshi Pharmaceutical (Zhongshan) Inc.
Effective date
2018-04-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 01:00:21

Label at a glance#

ProductNighttime Cold and Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections

Indications and uses

temporarily relieves common cold/flu symptoms: cough due to minor throat & bronchial irritation sore throat headache minor aches & pains fever runny nose & sneezing

Dosage and administration

take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (IN EACH SOFTGEL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

Dextromethorphan HBr 15mg

Doxylamine succinate 6.25mg

PURPOSES

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

USES

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches & pains
  • fever
  • runny nose & sneezing

WARNINGS

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks daily while using this product

Sore throat warning: if sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional

conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

  • to make a child sleep

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • Liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

.

Overdose warning

OVERDOSAGE SECTION

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control

Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults & children 12 yrs & over

2 softgels with water every 6 hrs

children 4 to under 12 yrs

ask a doctor
children under 4 yrsdo not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • store at room temperature

TAMPER EVIDENT: This package is safety sealed & child resistant. Use only if blisters are intact. If difficult to open, use scissors.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

D&C Yellow # 10, FD&C Blue # 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call toll free 1-844-374-0016

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nighttime Softgels

NDC: 11788-017-00

Quantity: 4,500 Softgels

WARNING:

KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11788-01711788-017-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C GREEN NO. 33P3ONR6O1SIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ACETAMINOPHEN362O9ITL9DACTIB
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c351766d-292f-d21d-e053-2a95a90acc4763754cf1-2cbd-801a-e053-2991aa0a3e012021-05-27WarningsExact identifier
spl set id: 63754cf1-2cbd-801a-e053-2991aa0a3e01

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.